Bioanalytical QA Executive

Job Title:

Executive – R&D Quality GCP QA

Business Unit:

Sun R&D Quality

Job Grade

G12A

Location :

Gurugram

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key responsibilities:

• Conduct audit of BA/BE studies, which includes bioanalytical in-process audits, bioanalytical retrospective audits, pharmacokinetic and statistical audits etc.
• Perform other QA audits like System/Facility/Process based audits.
• Create (review and/or coordinate) & implement Quality Assurance (QA) Standard Operating Procedures (SOPs) and global documents (GQSs/ GSOPs).  Review and support creation of operational level SOPs in collaboration with relevant stakeholders at R&D.
• Conduct Contract Research Organization (CRO)/ Contract Service Provider (CSP) / Material supplier Qualification/ Re-qualification audits.
• Review study documents (e.g. study protocol, method validation and study raw data/ reports etc.) of BA/BE studies in order to ensure compliance with applicable guidelines, regulations and Good Documentation Practice (GDP).
• Review Physiologically Based Pharmacokinetic (PBPK) / Physiologically Based Biopharmaceutics (PBBM) model report(s) generated at Sun Pharmaceutical Industries Limited.
• Review SOPs/ GSOPs, ATP, instrument qualification (IQ/OQ/PQ/DQ) etc.
• Review QMS records including Deviation, Incident, Temporary change control, Investigation, CAPA and change control etc.
• Prepare audit reports within timely manner; identify any non-compliance/ non-conformance and escalate any critical issue immediately with the QA management, as applicable.
• Support for conduct of regulatory inspection in collaboration with other R&D stakeholders. Collaborate for creation and implementation of appropriate CAPA for the identified gaps and resolution of regulatory queries in a time bound manner
• Impart or assist in imparting training on applicable guidelines, regulations, SOPs etc.

Travel Estimate

Nil

Job Requirements

Educational Qualification

Minimum graduate / post graduate degree in basic sciences

Experience

Tenure:  At least 02-03 years of experience in BA/BE environment, preferably in QA. Experience in conducting/ reviewing Physiologically Based Pharmacokinetic (PBPK) / Physiologically Based Biopharmaceutics (PBBM) studies preferred.

Technical Competencies:

• Understanding of international GCP/ GLP regulations and clinical research processes.
• Experience/ Understanding of GCP/ GLP Quality programs.
• Knowledge and understanding of auditing skills.
• Knowledge and understanding of pharmacokinetics and statistical analysis and tools preferred.
• Knowledge of IT/computer systems.

Behavioral Competencies / Soft Skills:

• Drive to achieve results
• Ability to work in team
• Flair for customer centricity
• Good written and verbal communication skills